Efficacy Study Comparing 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine

This study is currently recruiting participants.
Verified May 2013 by Mount Sinai Hospital, Canada
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Vibhuti Shah, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01270776
First received: January 4, 2011
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to compare the efficacy of two different antiseptic solutions (2%chlorhexidine in 70% alcohol with 2% aqueous chlorhexidine)when used in a standardized controlled manner in cleansing the skin of infants with birth weight less than 1500 grams prior to a skin breaking procedure (venepuncture).

The investigators hypothesize that the use of limited amount of 2% aqueous chlorhexidine solution will be as effective as the same amount of 2% chlorhexidine in 70% alcohol for skin antisepsis and that limited exposure to 2% aqueous CHG may be associated with less adverse skin reactions.

Literature from adults has shown that both 2% chlorhexidine in 70% alcohol as well as 2% aqueous chlorhexidine can provide effective skin antisepsis though alcohol containing solution had more long lasting effect. It is also well known from many case reports that alcohol containing products when used to clean abdominal skin for neonatal procedures can cause severe skin damage in preterm infants. This has lead many neonatal units to adopt aqueous chlorhexidine as the antiseptic agent of choice without robust evidence to support its use or standardization of method of application.Both these solutions are widely used in neonatal intensive care units across the globe including Canada.

By conducting this trial, the investigators want to evaluate the efficacy and safety of 2% aqueous chlorhexidine as an antiseptic agent when used in a controlled manner [limited amount for short duration].


Condition Intervention
Anti-infecting Agents, Local
Drug: 2% aqueous chlorhexidine
Drug: 2% Chlorhexidine 70% isopropyl alcohol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of 2% Chlorhexidine in 70% Isopropyl Alcohol Versus 2% Aqueous Chlorhexidine for Skin Antisepsis Prior to Venepuncture in Very Low Birth Weight Infants: A Planned Non-inferiority Trial

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Bacterial colony count as assessed by pre- and post cleansing skin swab culture. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    A sterile cotton swab with be rolled 4 times across the sampling area. The swab will be broken off into tube containing 1ml of sterile normal saline. A 0.1ml aliquot of this solution will be spread onto a blood agar plate. Colony forming units (CFU) will be enumerated after aerobic incubation at 37°C for 24 hours. Swabs which yield CFU > 15 will be labeled positive for bacteria and negative if CFU < 15.


Secondary Outcome Measures:
  • Immediate or late Skin reactions. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
    Local adverse events will be recorded by researcher at 10 minutes after the procedure and then again at 2, 12 and 24 hours later to monitor for immediate and late local reactions. Adverse events will be recorded using a validated contact dermatitis score.


Estimated Enrollment: 462
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aqueous Chlorhexidine
The group received skin antisepsis using 2% aqueous chlorhexidine solution.
Drug: 2% aqueous chlorhexidine
A single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.
Other Name: SOLU-I.V. Aqueous Swabsticks
Active Comparator: 2% Chlorhexidine 70% isopropyl alcohol
The group will receive skin antisepsis with 2% chlorhexidine solution in alcohol.
Drug: 2% Chlorhexidine 70% isopropyl alcohol
single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.
Other Name: SOLU-I.V. Swabsticks

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight < 1500 grams
  • Postnatal age > 48 hours and < 28 days
  • Need for venepuncture for any medical indication

Exclusion Criteria:

  • Birth weight ≥ 1500 grams
  • Infants with skin breakdown or previously documented to have skin reactions to antiseptic agent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01270776

Contacts
Contact: Vibhuti Shah, MD MRCP 001-416-586-4800 ext 4816 vshah@mtsinai.on.ca
Contact: Amish Jain, MD MRCPCH 001-416-454-3013 amish.jain@utoronto.ca

Locations
Canada, Ontario
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Vibhuti Shah, MD MRCP    001-416-586-4800 ext 4816    vshah@mtsinai.on.ca   
Contact: Amish Jain, MRCPCH (UK)    001-416-454-3013    amish.jain@utoronto.ca   
Principal Investigator: Vibhuti Shah, MD MRCP         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
The Physicians' Services Incorporated Foundation
Investigators
Study Chair: Vibhuti Shah, MD MRCP Mount Sinai Hospital, New York
  More Information

Publications:
Baumgartner C, Constant H, Putet G, Aulagner G. Cutaneous antiseptic efficacy of two ethanol chlorhexidine dilutions for neonatal venepuncture. Journal De Pharmacie Clinique 1998;17:109-12.
Lilley C, Powls A, Gray A. A prospective randomised double blind Comparison of 0.5% versus 0.05% aqueous Chlorhexidine for skin antisepsis prior to line insertion in neonates. Arch. Dis. Child. 2006;91;17-19.

Responsible Party: Vibhuti Shah, Staff Neonatologist, Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01270776     History of Changes
Other Study ID Numbers: 10 - 0112 - E
Study First Received: January 4, 2011
Last Updated: May 13, 2013
Health Authority: Canada: Health Canada

Keywords provided by Mount Sinai Hospital, Canada:
Randomized Controlled Trial
Chlorhexidine
Infant, Premature

Additional relevant MeSH terms:
Ethanol
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on April 17, 2014